EMEA-003053-PIP01-21 - paediatric investigation plan

Phospholipid esters from herring roe (HRO350)

Key facts

• Active substance:
  Phospholipid esters from herring roe (HRO350)
• Therapeutic area:
  Dermatology
• Decision number:
  P/0072/2022
• PIP number:
  EMEA-003053-PIP01-21
• Pharmaceutical form(s):
  • Age appropriate oral liquid dosage formulation
  • Age appropriate oral solid dosage form
  • Capsule, soft
• Condition(s) / indication(s):
  Treatment of psoriasis
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  11/03/2022
• Compliance check done:
  No

Decision

P/0072/2022 : EMA decision of 11 March 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral for phospholipid esters from herring roe (HRO350) (EMEA-003053-PIP01-21)

Adopted Reference Number: EMA/71127/2022